# Regulatory Affairs & Quality Assurance Director at Refeyn

- Company: Refeyn
- What the company does: Arago Biosciences is specializing in label-free single molecule imaging and mass measurement. Backed by Oxford Science Enterprises.
- Company website: https://refeyn.com
- Type: Startups
- Level: Principal and up
- Location: Oxford
- Work setup: On-site
- Posted: 2026-09-15
- Apply by: 2026-10-30
- Apply: https://job-boards.eu.greenhouse.io/refeyn/jobs/4974309101
- Page: https://www.1752.vc/careers/jobs/refeyn-regulatory-affairs-and-quality-assurance-director/

## About the role

The RAQA Director , is responsible for the strategic development and execution of the Company's regulatory affairs and quality assurance programs. Refeyn's products are currently sold as research/laboratory instruments rather than medical devices or IVDs, so this role is accountable for general product compliance (e.g. product safety, EMC, labelling, export/customs classification) across the US, EU, NMPA and other major global markets, rather than medical device-specific registrations.

## What they're looking for

- University Degree in Life Sciences or Engineering. Equivalent combination of education
- Familiarity with GAMP 5 and computer system validation concepts where instrument software or data touches GMP records
- Demonstrated success leading cross-functional teams in the development, implementation, application, and maintenance of eQMS platforms and regulatory submission processes
- Strategic, tactical and hands-on experience managing quality and regulatory frameworks within the company and across the supply chain and partnership base
- A hands-on leader with previous managerial experience who leads by example, inspires, and empowers team members
- Experience developing future quality and regulatory leaders and implementing organizational culture

Tags: Operations

Source: 1752vc Careers, https://www.1752.vc/careers/jobs/refeyn-regulatory-affairs-and-quality-assurance-director/